A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With … (NCT01156584) | Clinical Trial Compass
CompletedPhase 1
A Study of a Retroviral Replicating Vector Combined With a Prodrug Administered to Patients With Recurrent Malignant Glioma
United States54 participantsStarted 2010-07
Plain-language summary
This is a multicenter, open-label, ascending-dose trial of the safety and tolerability of increasing doses of Toca 511, a Retroviral Replicating Vector (RRV), administered to patients with recurrent high grade glioma (rHGG) who have undergone surgery followed by adjuvant radiation therapy and chemotherapy. Patients will receive Toca 511 either via stereotactic, transcranial injection into their tumor or as an intravenous injection given daily for 3 \& 5 days, depending on cohort. Approximately 3-4 weeks following injection of the RRV, treatment with Toca FC, an antifungal agent, will commence and will be repeated approximately every 6 weeks until study completion. After completion of this study, all patients will be eligible for enrollment and encouraged to enter a long-term continuation protocol that enables additional Toca FC treatment cycles to be given, as well as permits the collection of long-term safety and survival data.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* at least 18 years of age
* for intratumoral cohorts, supratentorial HGG (WHO grade III or IV)
* technically unresectable HGG
* initial definitive therapy such as surgery with or without adjuvant radiation
* subject elected not to undergo treatment with Gliadel wafer
* if receiving corticosteroids, dose is stable or decreasing for past 7 days
* KPS: at least 70
* absolute neutrophil count \> 1500/mm\^3
* absolute lymphocyte count \> 500/mm\^3
* platelet count \> 100,000/mm\^3
* hemoglobin \> 10 g/dL
* for intratumoral cohort, coagulation profile favorable to surgery
* estimated glomerular filtration rate \> 50 mL/min
* ALT \< 3 times ULN and bilirubin \< 1.5 mg/dL
* negative serum pregnancy test
Exclusion Criteria:
* cytotoxic therapy within the past 4 weeks (6 weeks for BCNU/CCNU)
* more than 2 recurrences including present recurrence
* Gliadel wafer or wafers implanted within the past 8 weeks
* taking more than 8 mg of dexamethasone per day
* for intratumoral cohorts, injection of tumor would require violation of ventricular system
* any infection requiring antibiotic, anticoagulant, or antiplatelet agents within the past 4 weeks
* for intratumoral cohort, bleeding diathesis or use of anticoagulants/antiplatelet agents that cannot be stopped
* allergy or intolerance to 5-FC
* HIV positive
* g.i. condition that would prevent ingestion or absorption of 5-FC
* any investigational treatment within the past 30 days
* pregnant or breast feeding
* received …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Feasible, Safe and Well Tolerated Dose of Toca 511